This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200.
This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200, administered orally under fasted and fed conditions. The study will enroll 18 healthy adult volunteers to ensure study completion of at least 12 evaluable volunteers. The study will be conducted in 3 groups, with each group enrolling 6 volunteers. As this is a crossover study, each volunteer will serve as their own control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Single dose of PBI-200
Bio-Kinetic Clinical Applications
Springfield, Missouri, United States
Time to Maximum Concentration [T(max)] of PBI-200
Tmax will be determined from the observed plasma concentration data.
Time frame: 7 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last measurable concentration [AUC(0-t)]
AUC, calculated using linear up/ log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.
Time frame: 7 days
AUC of PBI-200 from time zero to infinity [AUC(0-inf)]
AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/ kel, where kel is the terminal rate constant and Ct is the last measurable concentration.
Time frame: 7 days
Time of the maximum observed drug concentration [T(max)]
Time of the maximum observed drug concentration
Time frame: 7 days
Terminal elimination half-life [T(1/2)]
Apparent terminal elimination half-life, calculated as ln(2)/ kel.
Time frame: 7 days
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